The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

An effective CMC regulatory compliance strategy for biologics and biopharmaceuticals can seem like a mystery.  Through means of this 2nd edition, this no longer needs to occur.  A great deal of thanks goes to two regulatory authorities - the United States Food and Drug Administration (FDA) and the E...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Geigert, John (Autor)
Autor Corporativo: SpringerLink (Online service)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: New York, NY : Springer New York : Imprint: Springer, 2013.
Edición:2nd ed. 2013.
Temas:
Pharmaceutical chemistry.
Medicine-Research.
Biology-Research.
Pharmaceutics.
Biomedical Research.
Acceso en línea:Texto Completo
Tabla de Contenidos:
  • Complexity of Biologica CMC Regulation
  • Biologics are Not Chemical Drugs
  • An Effective CMC Strategy is Possible
  • Challenge of Adventitious Agent Control
  • Source Materials for Biologics
  • Manufacture of the Biologic API
  • The Biologic Final Product Process
  • Complex Process-Related Impurities
  • Molecular Structural Analysis
  • Functional Activity (Potency)
  • Setting Specifications and Expiry Dates
  • Demonstrating Product Comparability
  • CMC-Focused Regulatory Meetings
  • References.

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